FDA Device recall Z-1226-2014
VITROS Chemistry Products White Reference Slides, White Correction Factor Slide (WCF), DT Slides, 25 Slides, Part Number J02315
- FDA Device
- Class II
- terminated
- Published 2014-03-26
On 2014-03-26 the FDA classified a Class II recall of VITROS Chemistry Products White Reference Slides, White Correction Factor Slide (WCF), DT Slides, 25 Slides, Part Number J02315 by Ortho Clinical Diagnostics, citing an incorrect assay value (0.3785) was printed on the product carton for the 460 nm wavelength (filter) that may cause a delay in the ability to obtain and report TBIL, Bu, Bc, and….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1226-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-01-09 |
| Published | 2014-03-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS Chemistry Products White Reference Slides, White Correction Factor Slide (WCF), DT Slides, 25 Slides, Part Number J02315; Made in USA by Ortho- Clinical Diagnostics, Inc. 100 Indigo Creek Drive, Rochester, NY 14626 --- This product is a part/ tool used when performing the correction factors adjustment on the VITROS Chemistry Systems. It does not have a 510(k) number. Because the WCF slide is a part/ tool, and is not a device used for diagnostic testing, there is no Intended Use statement. The following summary is provided as a description/ explanation of the WCF slide. The WCF slide is a part/ tool used in the reflectometer correction factor adjustment procedure in order to optimize the optical calibration of the VITROS 250/350/5,1 FS/4600 Chemistry Systems and the VITROS 5600 Integrated
Reason
An incorrect assay value (0.3785) was printed on the product carton for the 460 nm wavelength (filter) that may cause a delay in the ability to obtain and report TBIL, Bu, Bc, and derived tests results. The correct assay value is 0.8658.
Identifiers
| code_info | Lot 9052-0045-6358, expiry date 01 Aug 2015 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1226-2014%22
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